Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

Inclusion Criteria:

Histologically or cytologically confirmed prostate cancer
Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment
Male, Age > 18 years
ECOG (Eastern Cooperative Oncology Group) performance score of 0-2
Adequate bone marrow, renal and hepatic function
Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter

Exclusion Criteria:

Prior treatment with NRX 194204 or bexarotene (Targretin)
Presence of parenchymal brain metastases
History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment
Known HIV or hepatitis B or C infection
Life expectancy < 3 months
Patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone
Patients with a history of pancreatitis or at significant risk of developing pancreatitis